Blog Entries

Distinguishing Silicone Oil Particles: Implications for Drug Products

Tue, 31 Mar 2026 01:48:20 Z

Silicone oil is commonly applied to components involved in primary drug containment, primarily serving as a lubricant for elastomeric parts. For instance, silicone oil is commonly applied to rubber stoppers and plungers to facilitate machinability throughout the fill-finish process. Similarly, it is used on the inner surface of syringes to enable smooth and controlled movement of the piston during injection. However, silicone oil introduced into the primary container may migrate into the drug product, where it can appear as sub-visible particulate matter—an important critical quality attribute (CQA) of the final drug product.

Successfully Navigating Opportunities with On-Body Delivery Systems – Common Questions and Answers

Wed, 25 Mar 2026 14:39:07 Z

In the rapidly evolving landscape of drug delivery, on-body delivery systems (OBDS) continue to stand out as a sophisticated integration of medical devices and pharmaceuticals, collectively referred to as "combination products." These devices provide unique benefits that allow patients to administer large volumes of medicine in the comfort of their home. The additional benefit of a pre-programed OBDS allows for drug administration at predetermined times and dosages with minimal user intervention, thereby supporting patient adherence and, by extension, supporting clinical outcomes.

USP Draft Chapters on Contamination Control Strategies (CCS): What You Need to Know

Wed, 11 Mar 2026 12:42:53 Z

Contamination control is the cornerstone of sterile drug product manufacturing. As therapies become more complex and patient safety expectations rise, regulators and standards-setting bodies are sharpening their focus on holistic contamination control strategies. When the European Union, World Health Organization (WHO) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised the GMP Annex 1 guidelines for sterile medicinal products, it raised the bar on expectations of manufacturers and their sterile product suppliers, by extension. Since the publication date, several other global jurisdictions have adopted these guidelines into their national law or developed complementary requirements.

Smarter Lifecycle Management: Decisions That Scale With You

Tue, 03 Mar 2026 12:49:24 Z

In the complex world of pharmaceutical development, drug developers have a lot to think about. From formulation and testing to containment and delivery, every decision carries risk, cost, and long-term implications. Making these decisions can be overwhelming in and of itself — but when you consider that the timing of each choice can influence the overall drug timeline, the challenge intensifies. These complexities call for a forward-thinking approach — one that considers not just today’s choices, but the ripple effects they create across the entire drug product lifecycle.
That’s why it’s critical not just to make the right decisions for the moment, but the smart ones that enable a successful launch — and, more importantly, ensure the long-term success and sustainability of your drug product.

Industry leaders share insights on QMSR Implementation Challenges & Audit Readiness

Wed, 25 Feb 2026 20:30:17 Z

The RAPS Philadelphia Chapter, in collaboration with West Pharmaceutical Services, convened regulatory, quality, and industry professionals for a dynamic session focused on the implementation of the FDA’s Quality Management System Regulation (QMSR). Held at West’s Exton, PA facility, the evening provided a collaborative forum for industry professionals navigating the transition from the longstanding Quality System Regulation (QSR) to the newly aligned framework modeled on ISO 13485.

Why Lower Endotoxin Levels Matter: Raising the Bar for Patient Safety and Product Quality

Wed, 18 Feb 2026 10:42:27 Z

The global pharmaceutical landscape continues to undergo rapid transformation. As the drug pipeline and the need for complex modalities such as biologics, advanced therapies, and mRNA-based treatments grow, the demand for high-quality, contamination-free primary packaging has never been greater. Regulators worldwide are challenging current practices and tightening standards, and patients are increasingly aware of final drug product safety. For pharmaceutical manufacturers, this translates into dual pressures; mitigating risk throughout the drug’s lifecycle and meeting stricter quality expectations to ensure patient safety and confidence.

Sustainability in Action: Supporting Local Communities Through the Honey Initiative

Tue, 10 Feb 2026 13:45:22 Z

Our honey bee hives are quite the ‘buzz’ here at West. Team members at our Eschweiler and Le Nouvion sites partner with local beekeepers to produce and sell honey in support of local charities in the community. Philanthropy is one of the key pillars that help shape the culture at West. We put a strong emphasis on giving back to the communities our employees live and work in.

Extractables and Leachables: Why They’re a Critical Part of Your Contamination Control Strategy Under EU GMP Annex 1

Thu, 05 Feb 2026 12:43:20 Z

When the European Union Good Manufacturing Practice (EU GMP) Annex 1 revision came into force, it reshaped expectations for sterility assurance. While much of the conversation has centered on aseptic processing and barrier technologies, one area that continues to gain attention is extractables and leachables (E&L)—especially in relation to primary packaging components.

Advancing Cell and Gene Therapies: The Role of West Vial Adapter™

Fri, 30 Jan 2026 12:17:23 Z

Cell and gene therapies (CGT) are at the forefront of medical innovation, offering potential cures for previously untreatable diseases. These therapies involve manipulating cellular and genetic material to treat or prevent illnesses. These therapies rely on the handling of fragile, high-value biological materials that must remain free from bioburden and other contamination, potent, and safe at every step—from manufacturing through clinical administration.

An Introduction to Parenteral Packaging: The Backbone of Safe and Effective Injectable Drug Delivery

Tue, 20 Jan 2026 15:58:02 Z

In an industry defined by innovation, one essential element quietly shapes the success of every injectable therapy: parenteral packaging. Parenteral packaging may sound technical, but its purpose is straightforward - it is the primary container system that holds, protects, and delivers sterile drug products to patients.
“Parenteral” refers to drug products administered by injection, bypassing the gastrointestinal tract. Depending on therapeutic requirements, these injections are delivered through several main routes, each chosen to optimize onset, duration, and patient experience (see illustration and table below).

Robotics and AI in Pharma: Driving the Next Wave of Innovation

Wed, 14 Jan 2026 10:00:14 Z

Pharmaceutical manufacturing is standing at the edge of a technological revolution. For decades, the industry relied on cam-driven systems, and more recently servo-driven mechanisms, to replicate basic human movements. Today, robotics and artificial intelligence (AI) are rewriting the rules of fill-finish operations, ushering in an era of precision, sterility, and adaptability.

Most frequently asked questions on the revised EU GMP Annex 1: Volume 8

Mon, 05 Jan 2026 15:09:53 Z

The 2022 revision of the European Union Good Manufacturing Practice (EU GMP) Annex 1, now in effect, has reset expectations for contamination control in sterile operations. The most consequential shift is the requirement for a site wide, documented Contamination Control Strategy (CCS) —a living framework that connects risks, controls, and monitoring across premises, equipment, utilities, personnel, materials, and processes.

Improving Diabetes Care with GLP-1 Drugs: Charting the Course for Change in Asia Pacific

Thu, 18 Dec 2025 15:55:40 Z

The global pharmaceutical landscape is experiencing a major shift with the rapid rise of Glucagon-like peptide-1(GLP-1) drugs. Market projections estimate the value of this sector will reach $150 billion by 2030¹, underscoring the scale and significance of this innovation in medical care.

West Volunteer Spotlight - Karin Bergstein

Wed, 17 Dec 2025 16:38:47 Z

Inclusive environments actively cultivate space where everyone feels valued, respected, and empowered. For West team member Karin Bergstein, Executive Assistant, QA, EU & General Management, Germany, inclusion is a driving force behind her passion to volunteer. Karin’s daughter, Klara, lives with a genetic defect known as MAC F1. Currently, there are 10 children worldwide with this diagnosis. This genetic defect causes neuronal migration, which often results in developmental delays and cranial nerve deficits. Those that are affected by MAC F1 have impaired intellectual development which can cause poor speech and social deficits, making independent living difficult.

Enhancing Drug Delivery with the West Vial Adapter™ Transfer Device: Key Insights and Implications

Tue, 09 Dec 2025 16:18:28 Z

As the healthcare landscape continuously evolves, the quest for safer, more efficient medical solutions remains a top priority for industry leaders. This involves leveraging cutting-edge technologies and innovative approaches to solve today’s healthcare challenges.

West Understands the “How” of USP <382>, We Are Here to Help You Figure Out the “What”

Mon, 01 Dec 2025 15:02:11 Z

In December of 2025, United Stated Pharmacopoeia will make official the final version of USP <382> “Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems”, focusing on the functional testing of container closure systems. The tests in this chapter go beyond the current functional testing regimen in USP <381>, which is specific to the elastomeric component, the stopper, in a vial drug system. USP <382> broadens the scope of functional tests from only a stopper and vial to nearly all drug delivery systems. Additionally, drug manufacturers will typically need to perform the testing to show the functional suitability of the system, as the final configuration and use case will need to be known and established.

Optimizing Primary Packaging for Injectable Drugs: Ensuring Safety, Efficacy, and Quality - Part 2

Tue, 25 Nov 2025 16:04:08 Z

Welcome back to our continued deep dive into packaging components. In Part 1, we explored key regulatory frameworks that shape packaging components in pharmaceuticals, such as USP <382> (effective from 01 Dec 2025), EU GMP Annex 1, and EU Medical Device Regulation (MDR) 2017/745. These guidelines underscore the importance of ensuring packaging components maintain drug integrity and safety, focusing on aspects like functional suitability, aseptic processing, and comprehensive compliance documentation.

Unveiling the Potential of West Vial Adapter™ Transfer Devices in Cell and Gene Therapy Applications

Wed, 19 Nov 2025 15:29:10 Z

The field of cell and gene therapies (CGT) is advancing rapidly, with an increasing number of therapies receiving approval for various conditions, ranging from rare genetic disorders to more common diseases like cancer. As the scope of treatable conditions widens, there is a parallel demand for advanced drug delivery systems that ensure these therapies are administered safely and effectively.

Most frequently asked questions on the revised EU GMP Annex 1: Volume 7

Tue, 04 Nov 2025 15:01:00 Z

In August 2022 the European Union revised its guidelines for sterile medicinal products for human and veterinary use. These guidelines came into effect on August 25, 2023. West has compiled the most frequently asked questions about Annex 1 and how it affects sterile drug manufacturers, which will be published across a multi-part series.

Optimizing Primary Packaging for Injectable Drugs: Ensuring Safety, Efficacy, and Quality - Part 1

Tue, 21 Oct 2025 13:57:41 Z

The primary packaging of injectable drug products plays a critical role in ensuring the safety, efficacy, and quality of the drug products. In this blog, we will explore the key considerations and methodologies involved in selecting the optimal primary packaging components for injectable drug products to ensure patient safety.

Building a Quality-Driven Culture to Lead in Regulatory Excellence

Wed, 15 Oct 2025 13:06:05 Z

At West, quality is more than a promise or a regulatory requirement — it's the foundation of everything we do to ensure we meet and exceed our customers' expectations while working to improve patient health. We recently rolled out a new Quality Policy across our organization, which highlights West’s commitment to a culture of excellence, emphasizing safety, sustainability, and continuous improvement.
By embedding quality into every aspect of our operations, West has established trust while also staying ahead of evolving regulatory requirements and Good Manufacturing Practice (GMP) standards.

Begin with the End in Mind: Defining a Pathway for Regulatory Success for Devices in Combination Products – Device Focus

Tue, 07 Oct 2025 11:41:44 Z

Begin with the End in Mind and the Four “Hows” of Regulatory Success

To achieve a “right first time” submission, it is essential to clearly define the end goals of the regulatory submission. One of the most important goals of a submission is to support the patient or end user by ensuring that the device is accessible in the given market. A good regulatory submission proves that the device is both safe and effective for its intended use. Another goal to meet business needs requires establishing a straightforward path to the intended market, with minimal questions, which in turn expedites product delivery to the end user. While this might seem obvious, these goals can sometimes be overlooked during the progression of a project.

Most frequently asked questions on the revised EU GMP Annex 1: Volume 6

Tue, 30 Sep 2025 13:25:58 Z

Leading the Pack: Our Support of Canine Service

Mon, 22 Sep 2025 17:28:24 Z

At West, our focus is on improving health for patients worldwide. We have had a commitment to giving back to the communities in which we lived and worked in for over a century. In recognition of September focusing on service dogs, we thought it would be a great opportunity to highlight some of the volunteer work and sponsorships West provides to two organizations globally. Canine Partners for Life in the United States and Handichiens in France. Read more to understand the great work the organizations do and our connections with them.

West Volunteer Spotlight: Rashmitha Kittur Mahadeva

Mon, 15 Sep 2025 15:06:36 Z

West team member, Rashmitha Kittur Mahadeva, Software Engineer, Robotics & Computer Vision, R&D in Bangalore, has shown a strong dedication to impacting her community. Passionate about community involvement, Rashmitha has actively participated in initiatives aimed at fostering change.

From Concept to Containment and Beyond: 5 Essential Elements of Packaging

Tue, 09 Sep 2025 15:32:07 Z

Are you making the best packaging decisions? Learn about the 5 essential elements to consider - your drug depends on it.

Embracing Our Culture of Giving Across the Globe

Thu, 04 Sep 2025 13:12:56 Z

West takes pride in cultivating a culture of giving, encouraging our team members worldwide to actively contribute time and resources to over 175 charities around the globe with a focus toward building a healthier world. This defining characteristic of fostering philanthropy and community engagement not only aligns with West's mission but also strengthens its impact on global health. This focus builds team member morale and community relationships and sets a powerful example for others to follow in creating a meaningful impact on the communities in which we live and work. This spirit of generosity is evident across our global locations. Check out some of the charities we support across the globe.

The Next Generation of West’s Knowledge Center: Improving the speed of doing business

Mon, 25 Aug 2025 15:55:50 Z

You need reliable technical documentation to support the packaging components and medical devices that you use to bring your drugs to market and deliver them to patients. And getting that documentation needs to be fast and easy. At West, we meet those needs through our Knowledge Center and the My Account portal.

West Opens New Analytical Laboratory in Stolberg, Germany

Wed, 20 Aug 2025 16:18:28 Z

This summer, West officially opened a new purpose-built analytical laboratory, housing approximately 80 team members near its manufacturing site in Stolberg, Germany.

Herman O. West Foundation Scholarship Awarded to Twenty-One Students Across the Country

Mon, 04 Aug 2025 14:54:23 Z

West employees’ students received $5,000 each year over four years, totaling $20,000 for higher education. While the selected student for the Chairman’s scholarship received $10,000 a year, totaling $40,000 over the four years.

Enhancing Patient Safety: Addressing Vial Coring Risks in Injectable Medications

Wed, 09 Jul 2025 05:32:42 Z

As drug manufacturers aim for higher safety standards and enhanced patient care, controlling the drug product at the point-of-use in a hospital or clinical environment remains a significant challenge. The method of vial access often varies, increasing the risk of adverse patient outcomes, such as stopper cores or fragments entering the drug product. If injected, these fragments can lead to cardiovascular events and other complications. Several factors contribute to stopper coring and fragmentation in the field, primarily influenced by the technique of the practitioner and the properties of the elastomeric closure.

Most frequently asked questions on the revised EU GMP Annex 1: Volume 5

Fri, 27 Jun 2025 17:35:31 Z

Solving the Challenges of Storage and Delivery of Gene Therapies

Fri, 20 Jun 2025 14:39:59 Z

Development in gene therapies is continually increasing – presently over 1,400 companies are involved, with over 2,200 clinical trials underway. It is essential to find an appropriate containment system to protect the time and monetary investments required to create these treatments.

Honoring Those Who Give the Gift of Life

Fri, 13 Jun 2025 10:00:10 Z

West is pleased to welcome guest blogger and valued corporate partner The American Red Cross

Most frequently asked questions on the revised EU GMP Annex 1: Volume 4

Wed, 04 Jun 2025 13:27:23 Z

Low Temperature Storage Containment for Vial and Syringe Systems

Tue, 27 May 2025 14:31:09 Z

Among the many sessions at the recent Parenteral Drug Association Week (formerly PDA Annual Meeting) in Palm Springs, CA, several focused on advanced therapy medicinal products (e.g., cell therapies, gene therapies), biosimilars, and disruptive therapies (e.g., live biotherapeutic products). With the growth of these therapies, there is an increased need for specialized low-temperature packaging solutions, particularly for vials and syringe systems at -50^oC to ≤ -130^oC.

Insight into our Germany site: The industrial mechanic apprenticeship

Mon, 12 May 2025 16:53:58 Z

The apprenticeship as an industrial mechanic at our Germany site offers basic experience in important areas. From day one, the aim is to learn the basics that will later be crucial for working with machines and in industry. An important part at the beginning of the training is the basic course – a kind of "training at the workbench" that helps the trainees to familiarize themselves with the basic skills.

Celebrating World Day for Safety and Health at Work: Sri City's Commitment to Excellence

Fri, 25 Apr 2025 17:30:32 Z

At West, safety is more than just a priority - it’s a core part of how we work together to protect and support one another. As we mark the World Day for Safety and Health at Work, we are proud to shine the spotlight on our Sri City team, whose commitment to creating a safe and healthy workplace has earned them well-deserved recognition.

Design and Building of Fixtures and Surrogates for Combination Product Performance Testing

Thu, 03 Apr 2025 11:38:23 Z

The combination product market has seen steady growth,ⁱ driven primarily by the rise in chronic disease indications, the demands for self-administered therapies and technological advancements in drug-delivery devices. Drug- or biologic-led combination products are typically a pharmaceutical product pre-packaged in a device that can be used for administration. The use of combination products simplifies the process of drug administration for the patient and/or the caregiver and, in some cases, allows the patient to receive treatment at home rather than having to travel to a medical facility, thus easing the burden on patients and helping facilitate drug regimen adherence. However, there are many challenges that need to be navigated as one considers the transition from a vial system to a needle-based combination product.

Planet Forward: – Reducing and Reusing Material for a More Sustainable World

Mon, 17 Mar 2025 15:55:08 Z

Today, we celebrate Global Recycling Day, and the vital role recycling material plays in securing the future of our planet. Our One West Team is dedicated to finding innovative solutions that reduce waste and promote a circular economy. Eliminating waste is a key sustainability priority for West, and our initiatives demonstrate our commitment to tackling climate challenges while meeting the expectations of our key stakeholders.

Sample Sizes for Performance Testing of Combination Products and Drug Packaging

Mon, 17 Feb 2025 15:55:31 Z

When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose. Numerous international standardsⁱand pharmacopeial chaptersⁱⁱ focus on functional performance testing and they all recommend conducting tests that simulate real-world conditions based on the intended use of the device or packaging. This simulation includes matching the physical properties of the drug when using placebos, duplicating the number of punctures and the expected needle size that would be encountered in actual practice and testing samples that had been conditioned with the appropriate sterilization treatments, transportation simulations, storage conditions and thermal exposure to approximate actual expected sample environmental exposure which might affect performance.

Most frequently asked questions on the revised EU GMP Annex 1: Volume 3

Mon, 03 Feb 2025 16:40:40 Z

4031/45 Ready Methods Reduce E&L Program Timelines

Mon, 20 Jan 2025 10:47:49 Z

In 21 CFR 211.94 it is stated that “Drug product containers and closures shall not be reactive, additive, or absorptive to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.” While the code makes this statement, and if expanded on in the related FDA Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics (May 1999), there is no prescription offered in how to execute an extractables and leachables evaluation, which is, of course, an essential aspect of demonstrating suitability of container closure systems.

Transitioning to Corning® Valor® Glass Vials: Enhancing Durability and Efficiency in Pharmaceuticals

Thu, 16 Jan 2025 11:43:08 Z

Traditional borosilicate glass vials, while being a long-standing staple in pharmaceutical packaging, can present certain limitations that may pose some challenges to drug manufacturers and healthcare providers.

Most frequently asked questions on the revised EU GMP Annex 1 : Volume 2

Mon, 06 Jan 2025 11:21:55 Z

Leachables Method Development and Validation and the Updated Relevant ICH References Part 3 – Method Validation

Thu, 19 Dec 2024 13:34:21 Z

This is part three of a three-part series about how recent updates to ICH Q2 and Q14 can be applied to the development and validation of leachables methods. Check out part one focused on the background and history of the updated ICH references and two focused on method development.

Most frequently asked questions on the revised EU GMP Annex 1: Volume 1

Tue, 03 Dec 2024 08:11:45 Z

West’s Taiwan Site Takes Home the Work-Life Balance Award

Tue, 26 Nov 2024 10:54:46 Z

The West Taiwan team was recently awarded the Work-Life Balance Award by the Ministry of Labor, Republic of China (Taiwan). This accolade highlights our ongoing commitment to creating a supportive and flexible work environment that prioritizes the well-being of our team members and fosters a culture of trust and innovation.

Leachables Method Development and Validation and the Updated Relevant ICH References – Part 2 – Method Development

Tue, 19 Nov 2024 17:06:45 Z

This is part two of a three-part series about how recent updates to ICH Q2(R2) and Q14 can be applied to the development and validation of leachables methods. You can find part one here.

West Setting New Standards: Success Stories in Apprenticeship Programs

Wed, 13 Nov 2024 14:16:32 Z

In today’s rapidly evolving business landscape, the need for skilled workers has never been greater. West has risen to this challenge by not just hiring talent, but also molding it through effective apprenticeship programs in collaboration with the Pennsylvania College of Technology (Penn College), a special mission affiliate of Pennsylvania State University. These initiatives have proven to be a resounding success.